Key Barriers to RWD Adoption
A new survey from Frost & Sullivan highlights the key barriers to adoption of real world data and analytics in health care and life sciences.
Makatsaria Takes Helm as CEO of LivaNova
Vladimir A. Makatsaria, who most recently served as Company Group Chairman at Johnson & Johnson MedTech, leading its global Ethicon surgery business, has been appointed CEO of global medical technology company LivaNova. Former CEO Bill Kozy will serve a Board Chair.
FDA Adopts ISO 13485 with QMSR Final Rule
Device manufacturers and importers will have two years to modify their Quality Systems to meet the requirements of the QMSR rule by February 2, 2026.
FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office
As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).
DiMe Convenes Industry Leaders to Streamline Commercialization of Digital Health Products
The Digital Medicine Society (DiMe) is partnering with PHTI, ZS, and other leading organizations to develop and launch core components of integrated evidence plans for digital health products to support faster regulatory approval and commercialization.
European Commission Proposes Extension for EU IVDR Compliance
If adopted, companies would have additional time—from 2027 to 2029, depending on the type of device—to gain approval under EU IVDR.
FDA To Host Town Hall on Medical Device Sterilization
“FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO),” the second in a series of medical device sterilization town hall discussions hosted by the FDA, will take place on January 26 from 12:00pm – 1:00pm ET.
FDA Approves Second Indication for Casgevy Cell-based Gene Therapy
Casgevy, a cell-based gene therapy for transfusion-dependent beta-thalassemia that utilizes CRISPR/Cas9 technology, was approved by the FDA following its application through the Fast Track and Regenerative Medicine Advanced Therapy (RMAT) programs.
MaryAnne Rizk Joins Blue Spark Technologies Board of Advisors
“We are incredibly fortunate to welcome Dr. Rizk to our advisory board. Her remarkable track record and profound knowledge in digital health will be invaluable as we continue to be at the forefront of redefining patient monitoring standards.”
FDA Announces Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge Winners
“The V-CHAMPS Challenge showed us that artificial intelligence (AI) models that performed well on the synthetic patient data in Phase 1 also performed well on the RWD during Phase 2, highlighting the potential value of using synthetic data in AI model development.”
